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I-FOBT HEMOGLOBIN NS-PLUS (2017-12-08)
- Starting date:
- December 8, 2017
- Posting date:
- December 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65492
Affected products
I-FOBT HEMOGLOBIN NS-PLUS
Reason
FOBT Hemoglobin NS-Plus reagent demonstrated unexpected increased positivity rate in screening for hemoglobin in feces. This positive rate increase only is apparent when screening for hemoglobin at 50 ng/mL and limited to the indicated lots.
Affected products
I-FOBT HEMOGLOBIN NS-PLUS
Lot or serial number
NL05
NN03
NT03
YO06
Model or catalog number
910113
Companies
- Manufacturer
-
ALFRESA PHARMA CORPORATION
18 TAIHEIDAI SHOUOU-CHO
KATSUTA-GUN, OKAYAMA
709-4321
JAPAN